PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

NCT02615730 | Completed Phase 1 DMC

• 1 other identifier: 4-2015-0204
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma.

Conditions

Advanced Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Recommended Phase II dose

  Recommended Phase II dose for phase 1

  4 weeks

• Progression-free survival

  Progression-free survival for phase 2

  6 weeks

Secondary Outcomes (1)

• Dose limiting toxicity

  28 days

Study Arms (1)

Paclitaxel & GSK2636771

EXPERIMENTAL

Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily) in combination with a fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)

Drug: GSK2636771; Drug: Paclitaxel

Interventions

GSK2636771 DRUG

Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily)

Paclitaxel & GSK2636771

Paclitaxel DRUG

fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)

Paclitaxel & GSK2636771

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
• Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory.
• Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure.
• Eastern Cooperative Oncology Group performance status of 0 or 1
• measurable or evaluable disease as determined by RECIST 1.1.
• Is able to swallow and retain orally administered medication
• adequate baseline organ function

You may not qualify if:

• prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors
• Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if hemoglobin is ≥9.0 g/dL)
• Has CNS metastases
• Has a QTc interval \>450 msec or QTc \>480 msec for subjects with bundle branch block (BBB)
• Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, NF such as paclitaxel.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

GSK2636771; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sun Young Rha

  Yonsei Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: February 1, 2016
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

KR (1)